MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-10 for TRYPTIC SOY BROTH 4.5 ML 06-5000 manufactured by Remel Inc..
[15604757]
Laboratory technician received a skin laceration when opening a 15 x 103 mmtest tube containing 4. 5ml tryptic soy broth (tsb). The event occurred when the technician attempted to remove the plastic screw-on cap from the tube. The cap was reported to be tight. The technician required medical treatment and recieved four (4) sutures on the outer side of the right thumb caused by tube breakage. The technician returned to non-restrictive duties.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924669-1998-00001 |
| MDR Report Key | 177894 |
| Report Source | 05 |
| Date Received | 1998-07-10 |
| Date of Report | 1998-06-10 |
| Date of Event | 1998-06-05 |
| Date Mfgr Received | 1998-06-10 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-07-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRYPTIC SOY BROTH 4.5 ML |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1998-07-10 |
| Model Number | NA |
| Catalog Number | 06-5000 |
| Lot Number | 5610 |
| ID Number | NA |
| Device Expiration Date | 1999-04-30 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 172980 |
| Manufacturer | REMEL INC. |
| Manufacturer Address | 12076 SANTA FE DR. LENEXA KS 66215 US |
| Baseline Brand Name | TRYPTIC SOY BROTH 4.5 ML |
| Baseline Generic Name | CULTURE MEDIA. |
| Baseline Model No | NA |
| Baseline Catalog No | 06-5000 |
| Baseline ID | NA |
| Baseline Device Family | CULTURE MEDIA, GENERAL NUTRIENT BROTH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-10 |